Harvesting cancellous bone and marrow from intramedullary canal formed in medullary cavity using bone press apparatus

ABSTRACT

Methods of harvesting cancellous bone and bone marrow include extracting loosened cancellous bone and bone marrow—including a liquid component thereof—to a collection container that has a first cup and a suction port to which a suction source is connected. After extraction, the suction source is disconnected and a lid of the collection container is removed and replaced with a lid having a plunger with a press head that is configured to filter the extracted liquid by depressing the plunger toward a bottom of the first cup. The filtered liquid is poured through a suction port into a second cup while depressing the plunger, thereby separating the liquid from a semi-solid mass of cancellous bone that remains. The bone is extracted through a cortical opening in the femur, tibia, or calcaneus, or from an intermedullary canal that is preferably formed by reaming of the tibia using an orthopedic reamer.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a continuation-in-part of, and claimspriority under 35 U.S.C. § 120 to, international patent applicationPCT/US20/40037 designating the United States, filed Jun. 28, 2020, thedisclosure of which is incorporated herein by reference, and whichinternational patent application is a U.S. nonprovisional patentapplication of, and claims priority under 35 U.S.C. § 119(e) to, each ofU.S. provisional patent application 62/868,855, filed Jun. 28, 2019,which '855 application is incorporated by reference herein; and U.S.provisional patent application 62/868,860, filed Jun. 28, 2019, which'860 application is incorporated by reference herein. Additionally, thepresent application is a U.S. nonprovisional patent application of, andclaims priority under 35 U.S.C. § 119(e) to, each of U.S. provisionalpatent application 62/868,855, filed Jun. 28, 2019, which '855application is incorporated by reference herein; and U.S. provisionalpatent application 62/868,860, filed Jun. 28, 2019, which '860application is incorporated by reference herein. The disclosures of the'855 and '860 applications are set forth in the appendices and thecomputer program listing, all of which is incorporated by referenceherein.

COPYRIGHT STATEMENT

Any new and original work of authorship in this document—including anysource code—is subject to copyright protection under the copyright lawsof the United States and other countries. Reproduction by anyone of thisdocument as it appears in official governmental records is permitted,but otherwise all other copyright rights whatsoever are reserved.

COMPUTER PROGRAM LISTING

Submitted concurrently herewith via the USPTO's electronic filingsystem, and incorporated herein by reference, are computer program filesincluding instructions, routines, and/or other contents of severalcomputer programs. A table setting forth the name and size of filesincluded in the computer program listing is included below.

File Name Creation Date File Size (bytes) ascify.txt Jun. 28, 2019 19:2637,473 readme-62868855.txt Jun. 28, 2019 19:27 2,780 one1.txt Jun. 28,2019 19:19 22478505 one2.txt Jun. 28, 2019 19:19 22478162 one3.txt Jun.28, 2019 19:19 6004473 readme.txt Jun. 28, 2019 19:37 2,781 two1.txtJun. 28, 2019 19:22 22478505 two2.txt Jun. 28, 2019 19:22 22478162two3.txt Jun. 28, 2019 19:22 22477819 two4.txt Jun. 28, 2019 19:2222477476 two5.txt Jun. 28, 2019 19:22 22477133 two6.txt Jun. 28, 201919:22 22476790 two7.txt Jun. 28, 2019 19:22 22476447 two8.txt Jun. 28,2019 19:22 22476104 two9.txt Jun. 28, 2019 19:22 22475761 two10.txt Jun.28, 2019 19:22 22475418 two11.txt Jun. 28, 2019 19:22 7518709

One of these files, “readme-62868855.txt”, contains instructions forextracting information from “one1.txt”, “one2.txt”, and “one3.txt”;“one1.txt”, “one2.txt”, and “one3.txt” collectively represent acompressed binary file that has been converted to ascii format. Thesefiles can be converted back to a compressed .zip archive utilizing anassembly conversion program source code for which is contained in“ascify.txt”. The readme file includes instructions for compiling andrunning this conversion program, and instructions for converting theother text files to a compressed, binary file. This compressed, binaryfile includes an .mp4 video file for a video illustrating aspects andfeatures in accordance with one or more preferred embodiments of theinvention relating to harvesting autologous cancellous bone and marrowfrom the proximal tibial.

One of these files, “readme.txt”, contains instructions for extractinginformation using “ascify.txt” from the other .txt files. The other .txtfiles named “twoX.txt”, where X=1 to 11, collectively represent acompressed binary file that has been converted to ascii format. Thesefiles can be converted back to a compressed .zip archive utilizing anassembly conversion program source code for which is contained in“ascify.txt”. The readme file includes instructions for compiling andrunning this conversion program, and instructions for converting theother text files to a compressed, binary file. This compressed, binaryfile includes four .mov video files illustrating aspects and features inaccordance with one or more preferred embodiments of the invention.

BACKGROUND OF THE INVENTION

The invention generally relates to methods and apparatus used forharvesting cancellous bone and marrow and, preferably, harvestingautologous cancellous bone and marrow from a distal femur, proximaltibia, distal tibia, or calcaneus of an individual for use as anautograft for that individual; and an intramedullary canal that isformed in a medullary cavity of a bone of an individual for use as anautograft for that individual, which bone of the medullar cavity may bethe tibia or the femur.

With regard to harvesting autologous bone, it is known when forming aintermedullary canal by reaming—which is basically done for a medullarynail—that autologous cancellous bone contained on the reamer afterwithdrawal may be recovered and used, if desired. Additionally withregard to specifically harvesting autologous cancellous bone and marrow,a procedure is known that is used for shallow-core harvesting ofcancellous bone and marrow from the posterior superior iliac spineimmediately prior to an anterior cervical discectomy/fusion (“ACDF”),wherein the harvested cancellous bone and marrow is used in thatindividual during the ACDF procedure. The procedure has been nicknamedthe “Ray Iliac Procedure” and is disclosed in U.S. patent application62/868,779 and in Ser. No. 16/916,012, both of which are incorporatedherein by reference. The Ray Iliac Procedure is intended for use in theorthopedic surgical field.

The Ray Iliac Procedure is based on a repurposed use of a bone pressapparatus as disclosed, for example, in U.S. Pat. No. 8,920,393, whichis incorporated herein by reference. Such bone press apparatus arecommercially sold by Hensler Surgical Products, LLC, of Wilmington, N.C.The bone press apparatus was designed for harvesting high-speed drilledbone during spinal procedures, which harvested bone was found to be amoldable and malleable matrix that could be reused in the patient toincrease fusion healing rates.

While the Ray Iliac Procedure is believed to be adequate for use inharvesting cancellous bone and marrow in conjunction with an ACDFprocedure, it is believed that additional improvements can be made inharvesting cancellous bone and bone marrow from other areas of the bodyby repurposing such bone press apparatus. Such additional improvementsare believed to be provided by one or more methods in accordance withone or more aspects and features of the invention, especially whenharvesting cancellous bone and bone marrow from condyles of the tibiaand femur and from the calcaneous, and when harvesting cancellous boneand bone marrow from an intermedullary canal formed in the tibia orfemur.

Indeed, it has been discovered that one or more methods in accordancewith one or more aspects and features of the invention result inunexpectedly high yields of cancellous bone and bone marrow, especiallywhen harvested from an intermedullary canal formed in the tibia orfemur; and unexpectedly high yield rates of cancellous bone and bonemarrow, especially when harvested from the condyles of the tibia andfemur and from the calcaneous, and from an intermedullary canal formedin the tibia or femur.

SUMMARY OF THE INVENTION

The invention includes many aspects and features. Moreover, while manyaspects and features relate to, and are described in, the context ofharvesting from a distal femur, a proximal tibia, a distal tibia, acalcaneus, and an intermedullary canal, the invention is not limited touse only in such areas. For example, it is contemplated that theinvention also is applicable to other areas, as will become apparentfrom the following summaries and detailed descriptions of aspects,features, and one or more embodiments of the invention.

Accordingly, in an aspect of the invention, a method of harvestingcancellous bone and bone marrow comprises the steps of: (a) creating anintermedullary canal, including loosening for extraction cancellous boneand bone marrow along the canal; (b) inserting a suction tube throughthe intermedullary canal and extracting the loosened cancellous bone andbone marrow along the intermedullary canal through the suction tube, thebone marrow comprising a liquid, the suction tube being attached to afirst lid of a collection container, the collection container having afirst cup and a suction port to which a suction source is connected; (c)after extracting the cancellous bone and bone marrow, disconnecting thesuction source from the suction port of the collection container; (d)removing the first lid of the collection container from the first cup ofthe collection container; (e) attaching a second lid to the first cup ofthe collection container, the second lid having a plunger with a presshead configured to filter the extracted liquid contained in the firstcup; (f) filtering the extracted liquid by depressing the plunger of thesecond lid toward a bottom of the first cup; and (g) pouring thefiltered liquid from the first cup through a suction port into a secondcup while depressing the plunger, thereby separating the liquid from aspongy semi-solid mass of cancellous bone that remains in the first cup.

In a feature, the step of creating the intermedullary canal is performedusing an orthopedic reamer, wherein the method further preferablycomprises collecting cancellous bone and bone marrow from the reamerafter withdrawing the reamer from the intermedullary canal.

In a feature, the intermedullary canal that is formed begins at a distalend of a tibia and extends along a longitudinal axis of the tibia towarda proximal end of the tibia.

In a feature, extracting the loosened cancellous bone and bone marrowalong the intermedullary canal comprises passing the suction tube in andout of the intermedullary canal while spinning the tube with one handand holding with the other hand the collection container to which thesuction tube is attached.

In a feature, extracting the loosened cancellous bone and bone marrowalong the intermedullary canal comprises passing the suction tube in andout of the intermedullary canal over a guide wire that extends withinthe intermedullary canal.

In a feature, the method further comprises pouring or drawing thefiltered liquid from the second cup into a syringe and injecting theliquid within an autograft or directly into an operative site to promotehealing.

In a feature, the method further comprises leaving the suction apparatusattached to the lid for repeating the harvesting method.

In a feature, no irrigation is performed during the method that woulddilute the extracted liquid.

In a feature, the second lid having the plunger additionally comprises avent, whereby a low pressure is not created within the first cup duringpouring of the liquid through the suction port while depressing theplunger.

In yet another feature, no suction is applied to the first cup duringdepressing of the plunger and pouring of the liquid from the first cup.In this respect, it will be appreciated that while the liquid is pouredthrough a “suction” port in preferred methods of the invention, suctionis not actually applied at this port; such reference to this port beinga “suction” port refers to the use of this port when the incorporatedbone press apparatus is used as originally intended in accordance withthe reference initially disclosing such bone press apparatus, namely,U.S. Pat. No. 8,920,393 incorporated by reference above.

In another aspect, a method of harvesting cancellous bone and bonemarrow comprises the steps of: (a) creating an opening in cortical bone;(b) accessing through the opening and loosening for extractioncancellous bone and bone marrow; (c) inserting a suction apparatusthrough the opening and extracting the loosened cancellous bone and bonemarrow, the bone marrow comprising a liquid, the suction apparatus beingattached to a first lid of a collection container, the collectioncontainer having a first cup and a suction port to which a suctionsource is connected; (d) after extracting the cancellous bone and bonemarrow, disconnecting the suction source from the suction port of thecollection container; (e) removing the first lid of the collectioncontainer from the first cup of the collection container; (f) attachinga second lid to the first cup of the collection container, the secondlid having a plunger with a press head configured to filter theextracted liquid contained in the first cup; (g) filtering the extractedliquid by depressing the plunger of the second lid toward a bottom ofthe first cup; and (h) pouring the filtered liquid from the first cupthrough a suction port into a second cup while depressing the plunger,thereby separating the liquid from a spongy semi-solid mass ofcancellous bone that remains in the first cup.

In a feature, the suction apparatus comprises a suction wand, andextracting the loosened cancellous bone and bone marrow preferablycomprises sweeping a distal end of the suction wand in variousdirections while extracting the loosened cancellous bone and bonemarrow, wherein the sweeping step is performed while holding thecollection container to which the suction apparatus is attached.

In a feature, the method further comprises pouring or drawing thefiltered liquid from the second cup into a syringe and injecting theliquid within an autograft or directly into an operative site to promotehealing.

In a feature, the method further comprises leaving the suction apparatusattached to the lid for repeating the harvesting method.

In a feature, no irrigation is performed that would dilute the extractedliquid.

In a feature, no suction is applied to the first cup during depressingof the plunger.

In a feature, the step of creating an opening in cortical bone comprisesusing a high-speed drill having a cutting burr to create the opening.The cutting burr preferably is used to create the opening and toloosening the cancellous bone and bone marrow for extraction that isaccessed through the opening. The cutting burr preferably is a 4 mmcutting burr or a 5 mm cutting burr. (As used herein, “burr” and “burand interchangeable and intended to mean the same thing.)

In a feature, the step of creating an opening in cortical bone comprisesusing a drill comprising a 4 mm cutting burr followed by replacing the 4mm cutting burr with a 5 mm cutting burr and continuing to use thedrill.

In a feature, the method preferably comprises using 6 mm and then 7 mmcurettes to increase the size of the opening when a large amount ofcancellous bone and bone marrow is needed.

In a feature, a maximum dimension of the opening created isapproximately 6 mm to 7 mm.

In a feature, a drill is used and the depth of drilling is between 1.8cm to 2.3 cm inclusive.

In yet another feature, 8 cc to 12 cc of cancellous bone and 10 cc to 15cc of bone marrow is obtained within 8 minutes.

Another aspects relate to a method of harvesting, from an individual, inan operating room and within 8 minutes, at least 8 cc to 12 cc of aspongy semi-solid mass of cancellous bone of the individual and,separated therefrom, at least 10 cc to 15 cc of liquid bone marrow ofthe individual. The method comprises: (a) using a high-speed drillhaving a cutting burr to create a cortical window in cortical bone; (b)further using the high-speed drill to loosen for extraction cancellousbone and bone marrow accessed through the cortical window; (c) insertinga suction apparatus through the cortical window and extracting theloosened cancellous bone and bone marrow, the bone marrow comprising aliquid, the suction apparatus being attached to a first lid of acollection container, the collection container having a first cup and asuction port to which a suction source is connected; (d) afterextracting the cancellous bone and bone marrow, disconnecting thesuction source from the suction port of the collection container; (e)removing the first lid of the collection container from the first cup ofthe collection container; (f) attaching a second lid to the first cup ofthe collection container, the second lid having a plunger with a presshead configured to filter the extracted liquid contained in the firstcup; (g) filtering the extracted liquid by depressing the plunger of thesecond lid toward a bottom of the first cup; and (h) pouring thefiltered liquid from the first cup through a suction port into a secondcup while depressing the plunger, thereby separating the liquid from aspongy semi-solid mass of cancellous bone that remains in the first cup.

In a feature, the cortical window is created in cortical bone at adistal tibia.

In a feature, the cortical window is created in cortical bone at adistal femur.

In a feature, the cortical window is created in cortical bone at aproximal tibia.

In a feature, the cortical window is created in cortical bone at acalcaneus.

In another aspect, a method comprises the steps of using a drill tocreate a cortical window in cortical bone and fragment trabecular boneunder the cortical bone; inserting a suction apparatus through thecortical window and sweeping the distal ends of the suction apparatus invarious directions to extract by suction cancellous bone and bone marrowof the fragmented trabecular bone, the suction apparatus being attachedto a collection container to which as suction source is connected;disconnecting the suction source from the collection container; removinga lid of the collection container from a cup of the collectioncontainer, to which lid the suction apparatus is attached; attaching asecond lid having a plunger with press head for filtering cancellousbone from bone marrow; depressing the plunger and compacting thecancellous bone against the bottom of the cup; and pouring bone marrowfrom the cup into another cup while depressing the plunger against thecancellous bone, thereby separating the bone marrow from the cancellousbone.

In a feature, the suction apparatus comprises a suction wand.

In a feature, the cortical bone is of the distal femur, proximal tibia,distal tibia, or calcaneus of an individual.

In a feature, the sweeping step is performed while holding thecollection container to which the suction apparatus is attached.

In a feature, the method further comprises pouring or drawing bonemarrow into a syringe and injecting the drawn bone marrow within theharvested bone graft or directly into an operative site to promotehealing.

In a feature, the method further comprises leaving the suction apparatusattached to the lid for repeating harvesting using another cup.

Other aspects comprise methods disclosed herein for harvestingcancellous bone and marrow.

Another aspect comprises a method includes steps for harvestingcancellous bone and marrow and, preferably, harvesting autologouscancellous bone and marrow from a distal femur, proximal tibia, distaltibia, or calcaneus of an individual for use as an autograft for thatindividual.

Another aspect comprises a method includes steps for harvestingcancellous bone and marrow and, preferably, harvesting autologouscancellous bone and marrow from an intramedullary canal that is formedin a medullary cavity of a bone of an individual for use as an autograftfor that individual, which bone of the medullar cavity preferably is thetibia or the femur.

Another aspect comprises apparatus that are used to perform the methodsdisclosed herein.

Additional aspects and features are disclosed in the appendices, thedisclosures of which are incorporated herein by reference, including thedisclosures and teachings of the videos.

In addition to the aforementioned aspects and features of the invention,it should be noted that the invention further encompasses the variouslogical combinations and subcombinations of such aspects and features.Thus, for example, claims in this or a divisional or continuing patentapplication or applications may be separately directed to any aspect,feature, or embodiment disclosed herein, or combination thereof, withoutrequiring any other aspect, feature, or embodiment.

BRIEF DESCRIPTION OF THE DRAWINGS

One or more preferred embodiments of the invention now will be describedin detail with reference to the accompanying drawings.

FIG. 1 is a flow chart of a preferred method of harvesting cancellousbone and bone marrow in accordance with one or more aspects and featuresof the invention.

FIG. 2 is a flow chart of another preferred method of harvestingcancellous bone and bone marrow in accordance with one or more aspectsand features of the invention.

FIG. 3 is a flow chart of another preferred method of harvestingcancellous bone and bone marrow in accordance with one or more aspectsand features of the invention.

FIG. 4 is a flow chart of another preferred method of harvestingcancellous bone and bone marrow in accordance with one or more aspectsand features of the invention.

FIG. 5 is a perspective view of components of a bone press apparatus ofone or more preferred embodiments in accordance with one or more aspectsand features of the invention.

FIG. 5 is a perspective view of a leg illustrating locations forharvesting of bone of one or more preferred methods in accordance withone or more aspects and features of the invention.

FIG. 6 is a perspective view of drilling a cortical window in thecortical bone of the tibia in accordance with one or more aspects andfeatures of the invention.

FIG. 7 is a perspective view of the suctioning of cancellous bone andbone marrow through the cortical window created in FIG. 6 to thecollection container of a bone press apparatus in accordance with one ormore aspects and features of the invention.

FIG. 8 is a table of case facts relating to a preferred harvesting ofthe invention performed in connection with the drilling and suctioningin FIGS. 6 and 7.

FIG. 9 is a perspective view of the pouring of filtered liquid from afirst cup into a second cup while depressing a plunger in accordancewith one or more aspects and features of the invention.

FIG. 10 is a perspective view of suctioning a cancellous bone and bonemarrow through a cortical window created in a tibia in accordance withone or more aspects and features of the invention.

FIG. 11 is a perspective view within the first and second cups after apreferred harvesting of the invention performed in connection with thepouring and suctioning shown respectively in FIGS. 9 and 10.

FIG. 12 is a table of case facts relating to a preferred harvesting ofthe invention performed in connection with the pouring and suctioningshown respectively in FIGS. 9 and 10, the results of which are seen inFIG. 11.

FIG. 13 is a table of case facts relating to another preferredharvesting of the invention performed in accordance with one or moreaspects and features of the invention.

FIG. 14 is a perspective view of the spongy mass of cancellous boneresulting from the preferred harvesting of FIG. 13.

FIG. 15 is a perspective view of the drilling of a medullary cavityperformed in a preferred harvesting in accordance with one or moreaspects and features of the invention.

FIG. 16 is a perspective view of reaming of a medullary canal followingthe drilling of FIG. 15, done in the preferred harvesting in accordancewith one or more aspects and features of the invention.

FIG. 17 is a view of reamers used in the reaming of FIG. 16, showingbone on the reamers which may be harvested and combined and used withthe bone that is suctioned in accordance with one or more aspects andfeatures of the invention.

FIG. 18 is a perspective view showing a suction tube to be inserted intothe intermedullary canal formed by the drilling and reaming respectivelyof FIGS. 15 and 16 done in the preferred harvesting in accordance withone or more aspects and features of the invention.

FIG. 19 is a perspective view of suctioning of cancellous bone and bonemarrow through the suction tube of FIG. 18 during insertion in theintermedullary canal.

FIG. 20 is a perspective view of the pouring of liquid from the firstcup into a second cup after the suctioning of FIG. 19 in the preferredharvesting in accordance with one or more aspects and features of theinvention.

FIG. 21 is a side view of the second cup following the pouring of FIG.20, showing liquid bone marrow that has been poured into the second cupduring performance of the preferred harvesting in accordance with one ormore aspects and features of the invention.

FIG. 22 is a table of case facts relating to the preferred harvesting ofthe invention performed in connection with the drilling, reaming,inserting, suctioning, and pouring shown respectively in FIGS. 15, 16,18, 19, and 20.

DETAILED DESCRIPTION

As a preliminary matter, it will readily be understood by one havingordinary skill in the relevant art (“Ordinary Artisan”) that theinvention has broad utility and application. Furthermore, any embodimentdiscussed and identified as being “preferred” is considered to be partof a best mode contemplated for carrying out the invention. Otherembodiments also may be discussed for additional illustrative purposesin providing a full and enabling disclosure of the invention.Furthermore, an embodiment of the invention may incorporate only one ora plurality of the aspects of the invention disclosed herein; only oneor a plurality of the features disclosed herein; or combination thereof.As such, many embodiments are implicitly disclosed herein and fallwithin the scope of what is regarded as the invention.

Accordingly, while the invention is described herein in detail inrelation to one or more embodiments, it is to be understood that thisdisclosure is illustrative and exemplary of the invention and is mademerely for the purposes of providing a full and enabling disclosure ofthe invention. The detailed disclosure herein of one or more embodimentsis not intended, nor is to be construed, to limit the scope of patentprotection afforded the invention in any claim of a patent issuing herefrom, which scope is to be defined by the claims and the equivalentsthereof. It is not intended that the scope of patent protection affordedthe invention be defined by reading into any claim a limitation foundherein that does not explicitly appear in the claim itself.

Thus, for example, any sequence(s) and/or temporal order of steps ofvarious processes or methods that are described herein are illustrativeand not restrictive. Accordingly, it should be understood that, althoughsteps of various processes or methods may be shown and described asbeing in a sequence or temporal order, the steps of any such processesor methods are not limited to being carried out in any particularsequence or order, absent an indication otherwise. Indeed, the steps insuch processes or methods generally may be carried out in variousdifferent sequences and orders while still falling within the scope ofthe invention. Accordingly, it is intended that the scope of patentprotection afforded the invention be defined by the issued claim(s)rather than the description set forth herein.

Additionally, it is important to note that each term used herein refersto that which the Ordinary Artisan would understand such term to meanbased on the contextual use of such term herein. To the extent that themeaning of a term used herein—as understood by the Ordinary Artisanbased on the contextual use of such term—differs in any way from anyparticular dictionary definition of such term, it is intended that themeaning of the term as understood by the Ordinary Artisan shouldprevail.

With regard solely to construction of any claim with respect to theUnited States, no claim element is to be interpreted under 35 U.S.C.112(f) unless the explicit phrase “means for” or “step for” is actuallyused in such claim element, whereupon this statutory provision isintended to and should apply in the interpretation of such claimelement. With regard to any method claim including a condition precedentstep, such method requires the condition precedent to be met and thestep to be performed at least once but not necessarily every time duringperformance of the claimed method.

Furthermore, it is important to note that, as used herein, “comprising”is open-ended insofar as that which follows such term is not exclusive.Additionally, “a” and “an” each generally denotes “at least one” butdoes not exclude a plurality unless the contextual use dictatesotherwise. Thus, reference to “a picnic basket having an apple” is thesame as “a picnic basket comprising an apple” and “a picnic basketincluding an apple”, each of which identically describes “a picnicbasket having at least one apple” as well as “a picnic basket havingapples”; the picnic basket further may contain one or more other itemsbeside an apple. In contrast, reference to “a picnic basket having asingle apple” describes “a picnic basket having only one apple”; thepicnic basket further may contain one or more other items beside anapple. In contrast, “a picnic basket consisting of an apple” has only asingle item contained therein, i.e., one apple; the picnic basketcontains no other item.

When used herein to join a list of items, “or” denotes “at least one ofthe items” but does not exclude a plurality of items of the list. Thus,reference to “a picnic basket having cheese or crackers” describes “apicnic basket having cheese without crackers”, “a picnic basket havingcrackers without cheese”, and “a picnic basket having both cheese andcrackers”; the picnic basket further may contain one or more other itemsbeside cheese and crackers.

When used herein to join a list of items, “and” denotes “all of theitems of the list”. Thus, reference to “a picnic basket having cheeseand crackers” describes “a picnic basket having cheese, wherein thepicnic basket further has crackers”, as well as describes “a picnicbasket having crackers, wherein the picnic basket further has cheese”;the picnic basket further may contain one or more other items besidecheese and crackers.

The phrase “at least one” followed by a list of items joined by “and”denotes an item of the list but does not require every item of the list.Thus, “at least one of an apple and an orange” encompasses the followingmutually exclusive scenarios: there is an apple but no orange; there isan orange but no apple; and there is both an apple and an orange. Inthese scenarios if there is an apple, there may be more than one apple,and if there is an orange, there may be more than one orange. Moreover,the phrase “one or more” followed by a list of items joined by “and” isthe equivalent of “at least one” followed by the list of items joined by“and”.

Referring now to the drawings, one or more preferred embodiments of theinvention are next described. The following description of one or morepreferred embodiments is merely exemplary in nature and is in no wayintended to limit the invention, its implementations, or uses.

Generally described, preferred methods of harvesting cancellous bone andbone marrow include extracting loosened cancellous bone and bonemarrow—including a liquid component thereof—to a collection containerthat has a first cup and a suction port to which a suction source isconnected. After suctioning, the suction source is disconnected and alid of the collection container is removed and replaced with a lidhaving a plunger with a press head that is configured to filter theextracted liquid by depressing the plunger toward a bottom of the firstcup. The filtered liquid is poured through a suction port into a secondcup while depressing the plunger, thereby separating the liquid from asemi-solid mass of cancellous bone that remains. The bone is extractedthrough a cortical opening in the femur, tibia, or calcaneus, andpreferably from a condyle; however, in other preferred methods the coneis extracted from an intermedullary canal that is formed by reaming ofthe tibia or femur using an orthopedic reamer.

Accordingly, FIG. 1 is a flow chart of an exemplary preferred method 100of harvesting cancellous bone and bone marrow in accordance with one ormore aspects and features of the invention. This preferred method isused to harvest such bone from the distal femur, proximal tibia, distaltibia, or calcaneous. The method 100 comprises steps 102 through 110.Step 102 comprises extracting loosened cancellous bone and bonemarrow—including a liquid component thereof—by suction to a collectioncontainer having a cup and a suction port to which a suction source isconnected. Step 104 comprises, after step 102, disconnecting the suctionsource from the suction port. Step 106 comprises replacing a lid ofcollection container with a lid having a plunger with a press head thatis configured to filter the extracted liquid by depressing the plungertoward a bottom of the cup. Step 108 comprises depressing the plungertoward the bottom of the cup to filter the extracted liquid. Step 110comprises pouring the filtered liquid from the first cup through asuction port into a second cup while depressing the plunger, therebyseparating the liquid from a semi-solid mass of cancellous bone thatremains in the first cup.

The suction port through which the liquid is poured in step 110 may bepart of the first cup or may be part of the lid having the plunger; inthe former case, the suction port to which the suction source isattached when performing step 102 is the suction port through which theliquid is poured in subsequent step 110, and in the latter case, thesuction port to which the suction source is attached when performingstep 102 is a suction port of the first lid, which first lid is replacedin step 106 by the second lid having the plunger. Moreover, it will beappreciated that the former case represents a modification to the cupdesign of the incorporated bone press apparatus, in which apparatus thecup itself does not include a suction port.

FIG. 2 is a flow chart of another preferred method 200 of harvestingcancellous bone and bone marrow in accordance with one or more aspectsand features of the invention. This preferred method is used to harvestsuch bone from an intermedullary canal formed in a medullary cavity. Themethod 200 comprises steps 202 through 214. Step 202 comprises creatingwithin a medullary cavity an intermedullary canal, including looseningfor extraction cancellous bone and bone marrow along the intermedullarycanal. Step 204 comprises inserting a suction tube through theintermedullary canal and extracting by suction through the suction tubethe loosened cancellous bone and bone marrow along the intermedullarycanal, wherein the bone marrow comprises a liquid, and wherein thesuction tube is attached to a lid of a collection container having a cupand a suction port to which a suction source is connected. Step 206comprises, after extracting the cancellous bone and bone marrow,disconnecting the suction source from the suction port. Step 208comprises removing the lid of the collection container from the cup ofthe collection container. Step 210 comprises attaching a second lid tothe cup of the collection container, the second lid having a plungerwith a press head that is configured to filter the extracted liquidcontained in the cup. Step 212 comprises filtering the extracted liquidby depressing the plunger of the second lid toward a bottom of the cup.Step 214 comprises pouring the filtered liquid from the cup through asuction port into another cup while depressing the plunger, therebyseparating the liquid from a spongy semi-solid cancellous bone mass thatremains in the cup.

The suction port through which the liquid is poured in step 214 may bepart of the first cup or may be part of the lid having the plunger; inthe former case, the suction port to which the suction source isattached when performing step 204 is the suction port through which theliquid is poured in subsequent step 214, and in the latter case, thesuction port to which the suction source is attached when performingstep 204 is a suction port of the first lid, which first lid is replacedin steps 208 and 210 by the second lid having the plunger. Moreover, itwill be appreciated that the former case represents a modification tothe cup design of the incorporated bone press apparatus, in whichapparatus the cup itself does not include a suction port.

FIG. 3 is a flow chart of another preferred method 300 of harvestingcancellous bone and bone marrow in accordance with one or more aspectsand features of the invention. This preferred method is used to harvestsuch bone from the distal femur, proximal tibia, distal tibia, orcalcaneous. The method 300 comprises steps 302 through 316. Step 302comprises creating an opening in cortical bone. The opening preferablyis made using a circular cutting burr, but other methods of creating anopening can in cortical bone may be used within the scope of theinvention, such as first drilling holes and then creating an openingwith a hammer and osteotome. One or more curettes also may be used tofurther expand the opening or round out the opening. Step 304 comprisesaccessing through the opening and loosening for extraction cancellousbone and bone marrow. Preferably the cutting burr also is used toperform such loosening Step 306 comprises inserting a suction apparatusthrough the opening and extracting the loosened cancellous bone and bonemarrow, wherein the bone marrow comprises a liquid and the suctionapparatus is attached to a collection container having cup and a suctionport to which a suction source is connected. Step 308 comprises, afterextracting, disconnecting the suction source from the suction port ofthe collection container. Step 310 comprises removing the lid from thecup of the collection container, and step 312 comprises attachinganother lid to the same cup, wherein the second lid has a plunger with apress head that is configured to filter the extracted liquid containedin the cup. Step 314 comprises filtering the extracted liquid bydepressing the plunger toward a bottom of the cup. Step 316 comprisespouring the filtered liquid from the cup through a suction port intoanother cup while depressing plunger, thereby separating the liquid froma spongy semi-solid cancellous bone mass that remains in the first cup.

The suction port through which the liquid is poured in step 316 may bepart of the first cup or may be part of the lid having the plunger; inthe former case, the suction port to which the suction source isattached when performing step 306 is the suction port through which theliquid is poured in subsequent step 316, and in the latter case, thesuction port to which the suction source is attached when performingstep 306 is a suction port of the first lid, which first lid is replacedin steps 310 and 312 by the second lid having the plunger. Moreover, itwill be appreciated that the former case represents a modification tothe cup design of the incorporated bone press apparatus, in which thecup does not have a suction port.

FIG. 4 is a flow chart of a preferred method 400 of harvesting from anindividual, in an operating room and within 8 minutes, at least 8 cc to12 cc of a spongy semi-solid mass of cancellous bone of the individualand, separated therefrom, at least 10 cc to 15 cc of liquid bone marrowof the individual, all in accordance with one or more aspects andfeatures of the invention. This preferred method is used to harvest suchbone from the distal femur, proximal tibia, distal tibia, or calcaneous.The method 400 comprises steps 402 through 416. Step 402 comprises usinga high-speed drill with a cutting burr to create a cortical window incortical bone. Step 404 comprises further using the high-speed drill toloosen for extraction cancellous bone and bone marrow accessed throughthe cortical window. Step 406 comprises inserting a suction apparatusthrough the cortical window and extracting with suction the loosenedcancellous bone and bone marrow, the bone marrow comprising a liquid,and the suction apparatus being attached to a lid of a collectioncontainer having a cup and a suction port to which a suction source isconnected. Step 408 comprises, after extracting, disconnecting thesuction source from the suction port. Step 410 comprises removing thelid from the cup. Step 412 comprises attaching another lid to the cupwhich lid has a plunger with a press head that is configured to filterextracted liquid contained in cup. Step 414 comprises filtering theextracted liquid by depressing the plunger toward a bottom of the cup.Step 416 comprise pouring filtered liquid from the cup through a suctionport into a second cup while depressing plunger, thereby separating theliquid from a spongy semi-solid cancellous bone mass that is leftremaining in the first cup.

The suction port through which the liquid is poured in step 416 may bepart of the first cup or may be part of the second lid having theplunger; in the former case, the suction port to which the suctionsource is attached when performing step 406 is the suction port throughwhich the liquid is poured in subsequent step 416, and in the lattercase, the suction port to which the suction source is attached whenperforming step 406 is a suction port of the first lid, which first lidis replaced in steps 410 and 412 by the second lid having the plunger.Moreover, it will be appreciated that the former case represents amodification to the cup design of the incorporated bone press apparatus,in which apparatus the cup itself does not include a suction port.

The incorporated components of the bone press apparatus that areutilized in preferred methods are perhaps best shown in FIG. 5. Thecomponents comprise a first cup 502 with a first lid 504 attachedthereto, and a second cup 506 with a second lid 508 attached thereto.The second lid 508 comprises a plunger 510 having a press head forfiltering liquid from cancellous bone and a suction port 512. The firstlid 504 also includes a suction port 514 and another port 516 forconnection to a suction apparatus or suction tube. The cups 502,506 inthe bone press apparatus are substantially identical and interchangeablewith each other. The bone press apparatus also includes an optionalelbow connector 524.

With reference now to U.S. patent application publication 2020/0405324(“the '324 Publ.”), which is incorporated herein by reference, apreferred suction tube 518 is shown in FIG. 6 of the '324 Publ., and asuction apparatus comprising a suction wand 520 is shown in FIG. 7 ofthe '324 Publ. The suction tube 518 preferably is used to connect thesuction wand 520 to the port 516 of the first lid 504 in certainpreferred methods of the invention that include harvesting of bone fromthe distal femur, proximal tibia, distal tibia, and calcaneous, all ofwhich areas are identified in FIG. 5.

Additionally, the suction tube 518 may be cut at desired length forminga distal end thereof for passing the distal end of the suction tube 518within an intermedullary canal when harvesting bone from theintermedullary canal, in which case the suction wand 520 is not used. Inthis respect, FIG. 8 also illustrates intermedullary canals formed inthe tibia and femur.

FIG. 9 of the '324 Publ. illustrates a collection container comprisingcup 502 and lid 504 connected by tubing 518 from port 516 to suctionwand 520. FIG. 9 of the '324 Publ. further illustrates another tube 522that connects a suction source (not shown) to suction port 512 of thelid 504.

FIG. 10 of the '324 Publ. illustrates the second lid 508 having theplunger 510 wherein the second lid 508 has been unscrewed and removedfrom the cup 506.

FIG. 11 of the '324 Publ. illustrates that lid 508 having the plunger510 may be screwed onto either of the two cups 502,506 of the bone pressapparatus, as the cups are interchangeable.

FIG. 12 of the '324 Publ. illustrates the second lid 508 screwed ontoone of the cups of the bone press apparatus.

Similarly, FIG. 13 of the '324 Publ. illustrates the lid 504 screwedonto one of the cups 502,506 of the bone press apparatus, and FIG. 14 ofthe '324 Publ. illustrates the first lid 504 unscrewed and removed fromthe cup of FIG. 13 of the '324 Publ.

FIGS. 15-18 of the '324 Publ. illustrate various views of anothersuction wand 620 used in preferred methods of the invention. As shown inthese figures, the suction wand 620 includes a slider control 622 bywhich suction that is applied at suction tip 624 of the wand 620 isvariably adjusted by a user.

FIG. 19 of the '324 Publ. illustrates the connection of the suction wand620 to the collection container comprising cup 502,506 and lid 504 foruse in certain preferred embodiments of the invention.

FIG. 20 of the '324 Publ. illustrates holding of the suction wand 620 toa collection container using suction tubing during use in certainpreferred embodiments of the invention. The wand 620 is used inpreferred methods by extending the suction tip thereof through acortical window for extraction, by suction, of cancellous bone and bonemarrow. The extracted cancellous bone and bone marrow is received andcollected in the collection container formed by lid 504 and one of thecups 502,506 of the bone press apparatus. The suction wand 620preferably has variable-suction control. Importantly, no irrigation isadded to the bone marrow that would dilute the bone marrow and,additionally, no suction is applied during use of the press head of theplunger and the separation of the bone marrow and cancellous bone bypouring of the bone marrow into the second cup through a suction port.

Harvesting of cancellous bone and bone marrow from a tibia, femur, orcancellous bone is now described for purposes of an exemplaryillustration of a preferred method in accordance with one or moreaspects and features of the invention.

In particular, FIG. 21 of the '324 Publ. is a perspective view of adrill 702with burr 704 coming within proximity of cortical bone 706.FIG. 22 of the '324 Publ. is a perspective view of the drill 702 beingused to form a cortical opening 708 in the cortical bone 706. FIG. 23 ofthe '324 Publ. is a perspective view of the drill 702 extended throughthe cortical opening 708 and being used to loosen cancellous bone andbone marrow. FIG. 24 of the '324 Publ. is a perspective view of thewithdrawal of the drill 702 from the opening 704. FIG. 25 of the '324Publ. is a perspective view of the apparatus of FIG. 20 of the '324Publ. being used to extract loosened cancellous bone and bone marrowthrough the opening 708 in the cortical bone 706. FIG. 26 of the '324Publ. is a perspective view of the approach of the suction tip 624 ofthe suction wand 620 to the opening 708 in the cortical bone 706. FIG.27 of the '324 Publ. is a perspective view of the extraction throughsuction of the loosened cancellous bone and bone marrow through theopening 708 in the cortical bone 706. FIG. 28 of the '324 Publ. isanother perspective view of the extraction through suction of theloosened cancellous bone and bone marrow through the opening in thecortical bone. FIG. 29 of the '324 Publ. is a perspective view of thewithdrawal of the apparatus of FIG. 20 of the '324 Publ. from theopening 708 in the cortical bone 706. FIG. 30 of the '324 Publ. is aview of the apparatus of FIG. 29 of the '324 Publ. after withdrawal andafter the suction source has been disconnected from the collectioncontainer. FIG. 31 of the '324 Publ. is a perspective view showing theremoval of the lid 504 from the cup 502,506 of the collection containerand further is a perspective view of the second lid 508 with plunger andsuction port 512 to be attached to the cup 502,506. FIG. 32 of the '324Publ. is a perspective view of the second lid attached to the cup andfurther is a perspective view of a second cup not which liquid 802 fromthe first cup is to be poured through the suction port of the secondlid. FIG. 33 of the '324 Publ. is a partial perspective view of thepouring of the liquid through the suction port of the second lid intothe second cup. FIG. 34 of the '324 Publ. is a perspective view of thesecond lid removed from the first cup, the first cup containing thespongy mass 804 of cancellous bone, and the second cup containing theliquid bone marrow 802. FIG. 35 of the '324 Publ. is a perspective viewshowing the withdrawal and staging of the spongy mass 804 of cancellousbone from the first cup.

Additionally, FIG. 6 is a perspective view of drilling a cortical windowin the cortical bone of the tibia in accordance with one or more aspectsand features of the invention. FIG. 7 is a perspective view of thesuctioning of cancellous bone and bone marrow through the corticalwindow created in FIG. 6 to the collection container of a bone pressapparatus in accordance with one or more aspects and features of theinvention. FIG. 8 is a table of case facts relating to a preferredharvesting of the invention performed in connection with the drillingand suctioning in FIGS. 6 and 7. FIG. 9 is a perspective view of thepouring of filtered liquid from a first cup into a second cup whiledepressing a plunger in accordance with one or more aspects and featuresof the invention. FIG. 10 is a perspective view of suctioning acancellous bone and bone marrow through a cortical window created in atibia in accordance with one or more aspects and features of theinvention. FIG. 11 is a perspective view within the first and secondcups after a preferred harvesting of the invention performed inconnection with the pouring and suctioning shown respectively in FIGS. 9and 10. FIG. 12 is a table of case facts relating to a preferredharvesting of the invention performed in connection with the pouring andsuctioning shown respectively in FIGS. 9 and 10, the results of whichare seen in FIG. 11.

FIG. 13 is a table of case facts relating to another preferredharvesting of the invention performed in accordance with one or moreaspects and features of the invention. FIG. 14 is a perspective view ofthe spongy mass of cancellous bone resulting from the preferredharvesting of FIG. 13.

Harvesting of cancellous bone and bone marrow from an intermedullarycanal is now described for purposes of an exemplary illustration of apreferred method in accordance with one or more aspects and features ofthe invention.

In particular, FIG. 15 is a perspective view of the drilling of amedullary cavity performed in a preferred harvesting in accordance withone or more aspects and features of the invention. FIG. 16 is aperspective view of reaming of a medullary canal following the drillingof FIG. 15, done in the preferred harvesting in accordance with one ormore aspects and features of the invention.

FIG. 17 is a view of reamers used in the reaming of FIG. 16, showingbone on the reamers which may be harvested and combined and used withthe bone that is suctioned in accordance with one or more aspects andfeatures of the invention. FIGS. 48 to 55 of the '324 Publ. areelevational views showing an exemplary creation of an intermedullarycanal in accordance with one or more aspects and features of theinvention, which is representative of the creation of the intermedullarycanal in the preferred harvesting of FIGS. 15 and 16 done in accordancewith one or more aspects and features of the invention. FIG. 18 is aperspective view showing a suction tube to be inserted into theintermedullary canal formed by the drilling and reaming respectively ofFIGS. 15 and 16 done in the preferred harvesting in accordance with oneor more aspects and features of the invention. FIG. 19 is a perspectiveview of suctioning of cancellous bone and bone marrow through thesuction tube of FIG. 18 during insertion in the intermedullary canal.FIG. 20 is a perspective view of the pouring of liquid from the firstcup into a second cup after the suctioning of FIG. 19 in the preferredharvesting in accordance with one or more aspects and features of theinvention. FIG. 21 is a side view of the second cup following thepouring of FIG. 20, showing liquid bone marrow that has been poured intothe second cup during performance of the preferred harvesting inaccordance with one or more aspects and features of the invention. FIG.22 is a table of case facts relating to the preferred harvesting of theinvention performed in connection with the drilling, reaming, inserting,suctioning, and pouring shown respectively in FIGS. 15, 16, 18, 19, and20.

As a result of the methods disclosed herein utilizing the bone pressapparatus with the suction for collecting both cancellous bone and bonemarrow and then separating the bone marrow from the cancellous boneusing the press head of the plunger, it has been discovered that anunexpectedly large yield of cancellous bone and bone marrow is obtainedfollowing intramedullary reaming. From actual implementation, 20 cc andmore of cancellous bone and 20 cc and more of bone marrow have beenobtained following traditional intramedullary reaming procedures used inconnection for an intramedullary nail or rod.

In recap of FIGS. 45-60 of the '324 Publ., which subsume FIGS. 15-17,and 18-22 hereof, preferred methods of the invention include harvestingcancellous bone and marrow from an intramedullary canal of an individualfor use as an autograft for that individual following drilling andreaming. An exemplary method is now set forth. In particular, a longpilot hole is created by a drill within the center of a long bone suchas the tibia. Drilling and intramedullary reaming loosens up thecancellous bone and marrow. Preferably, an intramedullary rod isinserted into the canal afterwards. Once depth of drilling to create theintramedullary canal is satisfactory for the surgeon, the reamer isused. The reamer is cannulated whereby the guide wire remains within thecanal the entire time. Multiple reamers are used and set aside forkeeping the bone to be added to the press later. The bone captured onthe reamers is scraped off with an instrument and used in the autograft.Once the reaming is complete, the bone press apparatus with suction isemployed. A suction line is cut approximately 2-3 feet and attached tothe silicon tubing. The tubing can be cut and the new suction tubing canbe placed over the superior port, but this is not necessary, as the bonepress apparatus preferably has a right angle for connecting the tubes.With suction on, the cut suction line is inserted around the guide wire.The guide wire does not leave the canal. Then by moving the suctiontubing all the way in and spinning the tubing in multiple in and outmotions within the canal and over the guide wire, cancellous bone andmarrow is harvested from the medullary cavity along the intramedullarycanal created by the intramedullary reaming. Once done, the collectionis handed off to the scrub tech and the press top is attached. Of note,suction is not applied when the press head is used. Instead, the plungeris fully pressed downward and the apparatus tilted to pour off theliquid marrow into a second container. Of note, suction is not appliedwhen the press head is used. Instead, the plunger is fully presseddownward and the apparatus tilted to pour off the liquid marrow into asecond container that is part of the bone press apparatus.

Based on the foregoing description, it will be readily understood bythose persons skilled in the art that the invention has broad utilityand application. Many embodiments and adaptations of the invention otherthan those specifically described herein, as well as many variations,modifications, and equivalent arrangements, will be apparent from orreasonably suggested by the invention and the foregoing descriptionsthereof, without departing from the substance or scope of the invention.Accordingly, while the invention has been described herein in detail inrelation to one or more preferred embodiments, it is to be understoodthat this disclosure is only illustrative and exemplary of the inventionand is made merely for the purpose of providing a full and enablingdisclosure of the invention. The foregoing disclosure is not intended tobe construed to limit the invention or otherwise exclude any such otherembodiments, adaptations, variations, modifications or equivalentarrangements, the invention being limited only by the claims appendedhereto and the equivalents thereof.

What is claimed is:
 1. A method of harvesting cancellous bone and bonemarrow, comprising: (a) creating an intermedullary canal, includingloosening for extraction cancellous bone and bone marrow along thecanal; (b) inserting a suction tube through the intermedullary canal andextracting through the suction tube the loosened cancellous bone andbone marrow along the intermedullary canal, the bone marrow comprising aliquid, the suction tube being attached to a first lid of a collectioncontainer, the collection container having a suction port to which asuction source is connected; (c) after extracting the cancellous boneand bone marrow, disconnecting the suction source from the suction portof the collection container; (d) removing the first lid of thecollection container from a first cup of the collection container; (e)attaching a second lid to the first cup of the collection container, thesecond lid having a plunger with a press head configured to filter theextracted liquid contained in the first cup; (f) filtering the extractedliquid by depressing the plunger of the second lid toward a bottom ofthe first cup; and (g) pouring the filtered liquid from the first cupthrough a port into a second cup while depressing the plunger, therebyseparating the liquid from a spongy semi-solid mass of cancellous bonethat remains in the first cup.
 2. The method of claim 1, wherein thestep of creating an intermedullary canal is performed using anorthopedic reamer.
 3. The method of claim 2, further comprisingcollecting cancellous bone and bone marrow from the orthopedic reamerafter withdrawing the orthopedic reamer from the intermedullary canal.4. The method of claim 1, wherein the intermedullary canal that isformed begins at a distal end of a tibia and extends along alongitudinal axis of the tibia toward a proximal end of the tibia. 5.The method of claim 1, wherein extracting the loosened cancellous boneand bone marrow along the intermedullary canal comprises passing thesuction tube in and out of the intermedullary canal while spinning thesuction tube with one hand and holding with the other hand thecollection container to which the suction tube is attached.
 6. Themethod of claim 1, wherein extracting the loosened cancellous bone andbone marrow along the intermedullary canal comprises passing the suctiontube in and out of the intermedullary canal over a guide wire thatextends within the intermedullary canal.
 7. The method of claim 1,further comprising pouring or drawing the filtered liquid from thesecond cup into a syringe and injecting the liquid within an autograftor directly into an operative site to promote healing.
 8. The method ofclaim 1, further comprising leaving the suction tube attached to thefirst lid for repeating the harvesting method.
 9. The method of claim 1,wherein the second lid having the plunger additionally comprises a vent,whereby a low pressure is not created within the first cup duringpouring of the liquid through the suction port while depressing theplunger.
 10. The method of claim 1, wherein no irrigation is performedthat would dilute the extracted liquid.
 11. The method of claim 1,wherein no suction is applied to the first cup during depressing of theplunger.